Instructions for Zoom Chairside Whitening System.

When you want to start to do something you have never done before, instructions are vital, especially if you are a healthcare worker, a dental professional. And even though a Zoom chairside whitening treatment seems to be incomparably easier than a complicated dental surgery, it requires following the protocol and taking all the nuances into account if you want to receive a painful and effective procedure.

Instructions for Zoom Chairside Whitening System.

Zoom Chairside Whitening Procedure Kit to be used with: Zoom Advanced Power (Zoom 2), Zoom Advanced Power Plus (Zoom 3) and Philips Zoom WhiteSpeed (Zoom 4) Lamps

IMPORTANT NOTE: The Discus Dental Zoom Chairside Whitening System is unique in both technique and formulation. Please read and understand information below prior to initiating whitening treatment.

Prior to use, Zoom Whitening Gel must be removed from refrigeration and warmed to room temperature.

To allow gel to return to room temperature either:

1. Remove syringe from refrigeration at least 6 hours before use (preferably the night before) or

2. If removed just prior to use, place syringe in cup of hot tap water, 120°F (49°C) for 10 minutes. Wait 5 minutes before extruding gel.

1. DEVICE DESCRIPTION

The Zoom Chairside Whitening System is a light-activated tooth whitening treatment for use in whitening discolored teeth.

2. HOW SUPPLIED

The product is designed for one-time usage. It may include Patient Post Care & Maintenance, to be sent home with patient after procedure, containing a tray case to hold custom fitted trays made from EVA material provided, a syringe of Relief® ACP Oral Care Gel for sensitivity relief and a syringe of NiteWhite® ACP, DayWhite® ACP or NiteWhite® ACP Turbo. Refer to Zoom Whitening Gel box for concentration of Hydrogen Peroxide (HP).

3. INDICATIONS FOR USE

Product is intended only for in-office use by trained dental professional for use in whitening discolored natural teeth.

3.1 Candidate Qualification

A consultation is recommended to ensure no underlying oral health issues. You may want to treat existing issues before recommending whitening treatment and disqualify any patient who is perio-involved, exhibits failing restorations or is otherwise in an unhealthy oral state.

3.2 Patients Expectations

Set realistic expectations about potential results based on oral exam. Explain results vary. Most will experience 6-8 shade change on value ordered VITA® Classical Shade Guide.™* Anatomy, calcifications, age, teeth condition, hygiene etc. determine the results each patient will attain. Teeth with yellow and brown stains will achieve greatest success while those with gray shading from tetracycline or other medications may experience less dramatic results but should improve. Crowns and other tooth-colored restorations will not whiten; to maintain uniform color, tooth-colored restorations may require replacement following whitening procedure.

4. CONTRAINDICATIONS

4.1 Use in Special Populations

Research has not evaluated possible effects of whitening procedures on all patient types, Discus Dental recommends the following whitening candidates consult a medical doctor before use:

• Pregnant and lactating mothers
• Those currently treated for a serious illness or disorder, e.g. immune compromised, AIDS, etc.
• Children under the age of 13 years
• Light sensitive individuals including those on PUVA (Psoralen + UV Radiation) or other photochemotherapy
• Those taking any photoreactive drugs or substances, whether over-the-counter, prescription or homeopathic

5. SAFETY DIRECTIONS

• Wear suitable protective clothing and eyewear
• Avoid contact with soft tissue and salivary flow
• Keep out of reach of children, in a cool place, away from combustible material

6. PRECAUTIONS

Improper isolation may result in burning of gingiva or swollen lips due to UV light coming in contact with tissue or chemical burn due to whitening gel coming in contact with tissue. Patients more susceptible to sensitivity are those with:

• known hypersensitivity
• untreated caries
• exposed root surfaces
• defective restorations
• oral tissue injury
• untreated periodontal disease

7. FIRST AID INSTRUCTIONS

Contact a Poison Information Center or medical doctor at once if large quantity (over 25% of syringe) is swallowed. Provide ingredient label if possible. Do not induce vomiting and immediately give glass of water. If Hydrogen Peroxide (HP) or Carbamide Peroxide (CP) gel gets into eyes, hold eyes open, flush continuously with water for 15 minutes. If contact occurs between whitening gel and soft tissue, apply Vitamin E Oil provided to the affected area. If improper isolation leaves patient’s soft tissue exposed to light, administer a Nonsteroidal Anti-inflammatory (NSAIDs) or Acetaminophen drugs (adhering to the respective Instructions For Use).

8. CHAIRSIDE WHITENING TREATMENT

8.1 (Step 1) Pre-Procedure

8.1.1 Take Shade

Prior to beginning, shade match teeth with value-ordered VITA® Classical Shade Guide.™* B1 A1 B2 D2 A2 C1 C2 D4 A3 D3 B3 A3.5 B4 C3 A4 C4

8.1.2 Diagnose Patient
Diagnose based on dental history, oral health and sensitivity issues (See 3.1 Candidate Qualifications). Set patient expectations accordingly (See 3.2 Patient Expectations).

8.1.3 Treat for Sensitivity

It is recommended to prescribe the following prior to the procedure:

• 5000 ppm Fluoridex Daily Defense® Sensitivity Relief with 5% KNO3. Instruct use of 2x/day, 14 days prior
• 600mg of Ibuprofen 1 hour prior
• Trays with Relief® ACP 10-30 minutes prior for extra sensitive patients

8.2 (Step 2) Preparation

8.2.1 Tray Fabrication

• Take accurate alginate/VPS impressions
• Pour models with stone, plaster or similar material, e.g. Speed Stone™, it solidifies quickly and allows for separation within 5-10 minutes
• Trim stone model so it extends 3-4mm past gingival margin
• With vacuum forming unit, heat supplied EVA material until it sags 15mm
• Lower tray material until directly above model, apply vacuum for 10 seconds
• Once cooled, cut off all gross excess material
• With small tray trimming scissors or heated scalpel, trim tray approximately 0.5mm from gingival margin
• Place tray on stone model, check gingival extensions
• If necessary, apply thin coat of medical grade silicone e.g. Speed Release® to labial surface and with low flame, gently heat and readapt margins. Entire tooth should be covered, but tray should not overlap gingival margin. Heat 5-6 teeth at a time, hold in place until the EVA material cools
• After all margins are readapted, re-trim any excess material. If areas are too short or perforated, reheat tray material and nudge in desired direction.
• Wash in cool, soapy water and cold sterilize. Place in Patient Post Care & Maintenance in tray case provided for storage. If patient is using existing trays ensure trays do not overlap gingival margin, as this may cause soft tissue irritation.

8.2.2 Clean Teeth

Pumice just prior to whitening.

8.2.3 Light Guide

Remove Light Guide and place on lamp. Turn on lamp using power button located on the side of power pack. When the Light Guide is attached, display will read “Guide Status–Guide Attached,” followed by “4 of 4 Sessions.”

8.2.4 Surgical Suction

Place surgical suction tip on high vacuum suction.

8.2.5 Vitamin E Oil

Apply Vitamin E Oil to lips to moisturize before retraction.

8.2.6 IsoPrep Retractor

Retractor provided is necessary to ensure proper positioning of lamp head and additional

protection from light. Insert retractor at an angle, (Fig 8.2a) retracting one side at a time using a dental mirror to assist in placement ( Fig 8.2b). The retractor provided is a universal size and will fit the majority of patients. Small retractors can be purchased separately.

8.2.7 “Before” Photo

Take retracted “before” photograph using a matched shade tab (Fig 8.2c).

8.2.8 Protective Eyewear

Fully recline patient and place Protective Eyewear (Fig 8.2d).

8.3 (Step 3) Isolation

8.3.1 Cotton Rolls

Place cotton rolls in center of upper and lower vestibules (Fig 8.3a). If cotton rolls are too large, unfold gauze and twist like a cotton roll.

8.3.2 Gauze

Do not substitute gauze. Gauze provided has been tested and proven to provide superior protection. Fully open gauze squares and fold into triangle. Place apex of triangle into posterior cheek (Fig. 8.3b & 8.3c), tuck balance of material into cheek, tucking ends between cotton rolls and retractor (Fig 8.3d).

8.3.3 Face Bib

Carefully place one face bib around retractor, one side at a time. Add additional bib for heavy salivatorius (Fig 8.3e).

8.3.4 Liquidam Dental Dam

Exposed dentin and tissue should be covered by barrier material. Use rule “no pink”. Remove Liquidam syringe, twist to remove cap and attach metal tip. Dry soft tissue and begin by scalloping barrier material to CEJ area (gingival margins) on upper teeth slightly overlapping enamel and interproximal spaces to form enamel seal (Fig 8.3f ). Cure application of Liquidam using curing light, e.g. FLASHlite Magna™ (Fig 8.3g). Liquidam is a resin blend that can become warm upon curing. Therefore, use sweeping motion, moving light back and forth across arch for about 10 seconds. Change to plastic tip. Fill in from cotton roll to just formed line of Liquidam and cure. Be sure to cover all interproximal areas leaving no soft tissue exposed (Fig 8.3h). On lower arch apply Liquidam, using same method. Use tip of syringe to press lightly on application to ensure it is completely cured. Material should be solid and have no give. If necessary, cure arch again for additional 5 seconds. Application should extend distal at least one tooth beyond area receiving whitening gel and be about 2mm thick.

8.4 (Step 4) Procedure

8.4.1 Zoom Whitening Gel

Remove cap of room temperature Zoom Whitening Gel syringe and attach mixing tip by aligning markings and secure with 1/4 turn clockwise. Apply gel to teeth (1-2 mm thick), using blue brush provided (Fig 8.4a). Use caution not to disturb barrier material. Gingival irritation can occur with prolonged exposure to HP gel.

8.4.2 Align Light Guide to Retractor

Once whitening gel application is complete, raise back of chair so patient is in slightly reclined position (~45 degree angle) and able to swallow comfortably while maintaining light pressure on bite block. The Light Guide is designed to ensure proper distance and alignment to maintain correct light exposure on smile zone. Slide lamp into place next to patient. Arm of lamp should be movable, but stable. Position lamp head by aligning slots on Light Guide with retractor (Fig. 8.4b)

8.4.3 Whitening Sessions

Follow prompts on display panel to turn on light and activate timer. Once light is on, a countdown will be displayed. It is normal for light to flicker for first few seconds. The lamp will beep once when 3 minutes are remaining and again 3 times on the final 3 seconds of cycle. When time reaches zero, light will turn off and a long beep will sound. If cycle must be interrupted, press “Pause” button. Remaining time will flash on display. To reactivate timer, press only “Pause” button. If step is not done, fourth 15 minute session will be LOST. Point out to patient that progress of each session will be tracked by 4 green lights on top of lamp head, each indicating one quarter of a session.
During each 15 minute session, make sure patient has means of communication, e.g. a bell, or do not leave the patient unattended. After each session, gently pull lamp away from patient taking care to not dislodge isolation materials. Carefully remove gel with surgical suction tip and/or wipe surface of enamel clean with damp gauze. Do not irrigate as force of water may pull dam loose and saturate isolation materials. Check isolation materials to ensure “no pink” tissue is visible. Replace or add isolation if needed. Follow same instructions as above for remaining sessions.
Note: For sensitive patients pull back lamp head within Light Guide or attach Light Guide Extender to further increase distance from light. However, please note these activities may reduce results, therefore a fourth 15 minute session may be needed

Tip: If patient notes irritation at margin use Vitamin E Oil to sooth tissue. If patient notes tooth sensitivity, place Relief ACP found in Patient Post Care & Maintenance, on lingual surface(s) for remaining sessions.
After last cycle is complete, detach Light Guide from retractor and pull lamp away from patient. Suction or wipe the whitening gel from teeth. Moisten gauze and cotton rolls, remove isolation materials. If barrier material remains interproximally, remove with floss.

9. POST TREATMENT

9.1 “After” Photo

Reinsert retractor, take retracted “after” photo with lighter shade tab in place. Measure shade change by counting shade shift according to value-ordered shade guide (Fig. 9.1a).

9.2 Relief® ACP ORAL CARE GEL

Relief ACP has been shown to decrease sensitivity and remineralize teeth. If patients experience sensitivity, place into take-home trays and seat on patient. Normal wear time is 10-30 minutes. If tray is not available, brush product on teeth. Do not spit for approximately 3 minutes. For best results, do not drink or eat for 30 minutes after application.

9.3 Patient Post Care & Maintenance

Instruct patient on use including Relief ACP and take-home whitening maintenance product.

9.3.1 Take-Home Whitening Maintenance

Use after 24 hours to maintain or to further enhance Zoom Chairside Whitening results. Depending on region, Zoom Kits are available with the following options:

• NiteWhite® ACP: 22% CP
• DayWhite® ACP : 9.5% HP
• NiteWhite® ACP Turbo : 6% HP

9.3.2 Maximizing Results

• Advise patient not to consume coffee, tea, red wine, and tobacco for 2 hours after Zoom, until pellicle reforms.
• All tooth whitening requires maintenance. The patient may choose to Zoom again or use maintenance product 1-3 nights every 4-6 months, depending on habits.

10. STORAGE INSTRUCTION

For Gel: Refrigerate gel at 2°C – 10°C (36°F and 50°F). Storage temperature above 10°C (50°F) will result in reduced shelf life.
Usage Temperature: >60°F/15°C